ROCKVILLE, Md., Sept. 26, 2007-The Food and Drug Administration
is alerting health care professionals and consumers to concerns
over the use of Fentora (fentanyl buccal) tablets after recent
reports of deaths and other adverse events.

Fentora, a potent opioid pain medication, is used only for
treatment of breakthrough pain in cancer patients receiving opioid
treatment and who have become tolerant to it. Breakthrough pain is
intense increases in pain that occur with rapid onset, even when
opioid pain-control medication is being used. Patients who take
narcotic pain medications daily and around-the-clock develop
tolerance and are more resistant to the dangerous side effects of
these medications than patients who take narcotic pain medication
on a less frequent basis.

The deaths reported were the result of improper selection of
patients, dosing, or improper product substitution.

"FDA is monitoring this issue very closely," said Steven Galson,
M.D., M.P.H., director of FDA’s Center for Drug Evaluation
and Research. "We are working with the manufacturer to ensure the
safest use of this medicine. Health care professionals and patients
need to be aware of the potential for fatal overdose with the
improper use of Fentora."

In its Public Health Advisory and Health Care Professional Sheet
published today, FDA warned physicians and other health care
professionals that it is critical to follow product labeling when
administering Fentora. FDA further stated that it is dangerous to
use Fentora for any short-term pain such as headaches or migraines.
It is critical that Fentora not be used in patients who are not
opioid tolerant.

Patients also must be under a doctor’s care and close
supervision while taking Fentora and the dose should be carefully
adjusted to control breakthrough pain adequately.

In addition, FDA is concerned about the improper substitution of
Fentora, a quick acting pain drug, for other pain medicines.
Fentora is not the same as other fentanyl products and cannot be
substituted for Actiq, another fentanyl product used to treat
breakthrough cancer pain. Because Fentora delivers more fentanyl to
the blood than Actiq, substituting Fentora for Actiq using the same
dose can result in a fatal overdose.

On Sept.10, 2007, Cephalon Inc., the manufacturer of Fentora,
sent letters to physicians and other health care providers advising
them about the adverse events and deaths reported for Fentora. FDA
is reviewing available information including adverse events. The
agency has asked the company to strengthen warnings and improve the
dosing instructions in the drug’s product labeling. FDA also
requested that the company improve their education plan for
prescribers and pharmacists on the proper patient selection, dosing
instructions and restrictions on substituting Fentora for other
products.